Novel Determinants and Measures of Smokeless Tobacco Use: Study 2
NCT ID: NCT01067599
Last Updated: 2018-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
278 participants
INTERVENTIONAL
2012-03-31
2016-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Low nicotine
Conventional smokeless tobacco product with 1) NNN plus NNK of \<2 μg/gram and nicotine levels of \>5 mg/g wet weight
Low nicotine
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
Medium nicotine
Conventional smokeless tobacco product with ) NNN plus NNK of \<2 μg/gram and nicotine levels of 3-5 mg/g wet weight.
Medium nicotine
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
High nicotine
Conventional smokeless tobacco product with NNN plus NNK of \<2 μg/gram and nicotine levels of \<3 mg/g wet weight
High nicotine
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
Interventions
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Low nicotine
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
Medium nicotine
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
High nicotine
Comparison of different dosages of nicotine effect on tobacco use patterns, subjective response and biomarker levels.
Eligibility Criteria
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Inclusion Criteria
2. In good physical health (no unstable medical condition);
3. Stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).
Exclusion Criteria
2. Female subjects cannot be pregnant or nursing.
18 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
National Institute on Drug Abuse (NIDA)
NIH
University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Dorothy Hatsukami, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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University of Minnesota
Minneapolis, Minnesota, United States
Oregon Research Institute
Eugene, Oregon, United States
Countries
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Other Identifiers
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